Collaborative Care in Posttraumatic Epilepsy

Not Applicable

Recruiting

• Conditions: Epilepsy, Post-Traumatic
• Interventions: Behavioral: SOC Neurological care; Behavioral: Neurology Based Collaborative Care

• Registration Number: NCT05353452
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

The purpose of this research is to evaluate a 6 month change in quality of life in subjects who receive collaborative care calls compared to those subjects who receive usual neurology care. This is a 2-site trial comparing a 24 week neurology-based collaborative care program to usual neurology care among a total of 60 adults with post-traumatic epilepsy.

Detailed Description

The study will compare collaborative care versus usual care among N=60 adults with post-traumatic epilepsy and anxiety and/or depression symptoms in Veterans Administration (N=20) and civilian university (N=40) settings at the Salisbury VA and Atrium Health Neurology. This single-blind study will evaluate effectiveness and implementation of a remotely-delivered, 24-week team-delivered collaborative care intervention, with features adapted from VA Primary Care Mental Health Integration and Whole Health, as well as an existing Family Medicine Collaborative Care Program at AHWFB.

Study Timeline

• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-29
• Study Start: 2023-04-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures

• Diagnosis of post-traumatic epilepsy, defined by the following:

  1. Epilepsy diagnosis based on neurology clinician impression of diagnosis or electroencephalogram (EEG) findings (EEG findings: presence of interictal epileptiform discharges on EEG or ictal EEG recording of seizure definitively documenting epilepsy diagnosis)
  2. History of at least mild traumatic brain injury based on the MIRECC (Mental Illness Research, Education, and Clinical Center) TBI (Traumatic Brain Injury) screening instrument or verified TBI history based on MIRECC research database
  3. TBI pre-dated onset of epilepsy (NINDS post-traumatic epilepsy screening form)

• Anxiety or depression symptoms--Generalized Anxiety Disorder scale (GAD-7) ≥8 or Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) >13

• Receiving clinical neurological care at one of the study sites

Exclusion Criteria

• Active ongoing treatment by a psychiatrist without the potential to benefit from additional collaborative care for anxiety or depression in the judgement of the investigators
• Active suicidal ideation
• History of past suicide attempt
• Unstable drug or alcohol abuse
• Unstable or progressive comorbid medical condition
• Current participation in another treatment or intervention study
• Cognitive limitations precluding completion of anxiety and depression self-report instruments on paper, electronically, or by interview.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care (SOC)	SOC Neurological care	Participants in this arm will receive provider-recommended clinic visits, prescriptions, testing, and referrals.
Collaborative Care	Neurology Based Collaborative Care	Participants in this arm will receive 24 weeks of neurology based collaborative care.

Primary Outcome Measures

Name	Time	Method
Emotional Subscale-Change in Quality of Life in Epilepsy-31(QOLIE-31)	Baseline through Month 6	This is a clinically meaningful patient reported outcome measure that was demonstrated to improve in collaborative care efficacy trials in distinct patient groups (including with various different types of medical illness) Score ranges from 0-100 with higher score indicating better quality of life

Secondary Outcome Measures

Name	Time	Method
Change in Beck Depression Inventory-II (BDI-II) score	From baseline through Month 6	Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms.
Subject Adherence to Intervention	Week 12	Proportion of intervention arm participants who attend 50% or more of the care management calls in the first 12 weeks of the intervention.
Change in Epilepsy specific QOLIE-31 score	Baseline through Month 6	Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life.
Change in Beck Anxiety Index (BAI) score	From baseline through Month 6	Anxiety symptom questionnaire-score ranges from 0-61, with higher score indicating more severe anxiety symptoms.

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist; 🇺🇸 Winston-Salem, North Carolina, United States